Your Company’s drive to make each person more productive than ever before has led to increasing convergence of the physical, digital, and biological processes and technology you perform into integrated software and automated systems. The past decade has seen the development of software supporting virtually all of the Life Sciences Industry, first as downloaded software and now, increasingly, as cloud-based software that is accessible to your entire organization from anywhere on multiple platforms. Innovative companies invest in software systems that support their continuous improvement in compliance and productivity.
How does a software system benefit the organizations?
- Provides a compliant, secure, flexible, and robust foundation for operations.
- Let’s you do more with less staff.
- Enforces your processes.
- Minimizes delays.
- Automates Tasks, Record Keeping, and Analytics
- Enables better decision making with input from data capture and analysis.
- The system does it your way, so you don’t change the way you work.
PSC SoftwareTM has the cloud-based software products that provide the full featured electronic Quality Management System with unparalleled flexibility to automate your entire business; the world-best, easy to learn, and easy to use real-time inspection management software; and the ready to use, plug-and-play electronic Quality Management System that comes complete with all the documents for your industry segment.
PSC Software Solutions:
- Adaptive Compliance Engine® (ACE™) is the full featured electronic Quality Management System that allows you to automate virtually any process. ACETM integrates a wide range of tasks into a comprehensive and seamless platform, including ACE Auditor™, ACE Analytics™, ACE Inspection™, ACE Docs™ for controlled document management, ACE LMS™ a fully integrated Learning Management System, and ACE PLM™ for Product Lifecycle Management. ACETM is the scalable and highly-configurable enterprise quality management system that easily adapts to any business process to enable tracking, management, and reporting of all compliance, quality, and operational activities in real-time.
- AuditUtopia® is the world’s-best, stand-alone, real-time inspection management system. AuditUtopia® is the software tool that allows your inspection team to streamline request handling and improve response time. AuditUtopia® is so easy to use that your entire team can learn to use AuditUtopia® in less than a day. AuditUtopia® is designed to keep your audit team organized, ensure a free flow of information, and address and track priorities. Whether you have any Quality Management System, when it comes to inspection management AuditUtopia® gives you all of this capability and more for an incredible price:
- Configurable Reports
- Log Inspection Notes
- Real-Time Updates
- Chatrooms and Private Chats
- In-System and Email Notifications
- Track and Manage Requests
- ACE Essentials™: ACE Essentials™ is the complete, fully validated, Turnkey Electronic Quality Management System (EQMS) software created for highly regulated industries. ACE EssentialsTM comes with all the necessary standard operating procedures and policies to deliver you fully compliant quality management system at an unbeatable price. ACE EssentialsTM includes document management; training management; deviation; investigation; corrective and preventive action; design control; risk management capabilities; and much more, ready to use and fully compliant.
Cloud-based Life Science Software lets your organization ensure compliance and data integrity, respond faster, reduce time to market, address regulatory issues efficiently, and ensure continuity.
If you need more than just software, PSC Biotech™ can provide your company a full range of professional services, including computer system validation, equipment and facility commissioning, qualification and validation, risk assessment, temperature mapping, staff augmentation, and more. PSC Biotech™ provides professional services as customized engagements tailored to your needs or under Master Services Agreements that allows you to use the services you need when you need them at an agreed cost. Our experienced consultants are ready to help your company succeed. Whatever your requirements, PSC Biotech™ will work with you to make it happen!
The impact of computer software on Biotech and medical industry is immense. Thanks to the advanced technology, we can rely on computer software to design experiments, interpret data, store data, and provide results. There are several types of software, including product specific software, laboratory management software, and software for bio-imaging. When it comes to considering new Computer Software for Biotechnology, it is highly important to investigate its compatibility of operating systems, drivers, and instrument components. Computer software can go outdated quickly, so look for its ability to upgrade.
The IT department in an institution may need a consultation to integrate new technology into laboratory information systems. It would be beneficial to look for the companies that provide friendly technology support to help you get your new system up as well as running.
Biotechnology Software in the Digital Age
The digital revolution has taken place everywhere, and biotechnology companies have also adapted it. There are a number of pharmaceutical, biotechnology, and industrial bio-production companies believe that computer software must be developed and maintained in-house so that the data can be safely stored on their internal servers than on the cloud. In fact, most of the reputed companies continue to employ large IT and software teams in order to obtain computational infrastructure in the form of in-house servers. This is because of the fear of the cloud not appropriately protecting their in-house resources and the belief that their software is precious IP.
Over the past years, the ability to adapt to the changing conditions of the market will become a compelling competitive benefit. Biotechnology companies that do not adapt to the new changes may lose on key business metrics, including capital, revenue, profitability, and market share as well.
Biotechnology – Introduction
Biotechnology is an industry prime for disruption for several reasons, including
- It is growing frequently with rapid IPO activity, which makes a market entrance for small start-ups with venture capital backing a high probability.
- The tools and techniques are highly advanced with the price of reading as well as writing DNA falling faster than Moore’s law predicts.
- Rising levels of investment in biology bring the size of Series B rounds to $50 million. It allows small companies to enter the space with completely automated laboratories as well as production capabilities.
- It increases the availability of affordable infinite computing capacity that removes the need for expensive, on-site infrastructure.
Software in Research & Development groups is covering behind the existing technology landscape. Industries employ smart people, pay them money, and provide poor tools to meet their design work. In many cases, a scientist works the applications that are less innovative, less protected, and deliver an inferior user experience as compared to the applications this same scientist can provide with advanced tools and technology. Talking about biotechnology, operations in most large and even small biotech companies are fully automated pipeline. Computer-aided manufacturing (CAM) for biology is solved.
The level of automation in the pharma laboratory matches advanced manufacturing facilities like those in the automotive world, and they can get the advantage from software advances in the computer-aided manufacturing world for over 40 years. Instead of developing software in-house, companies prefer to use off-the-shelf design and infrastructure management software for their automated lab designs and their factories as well as production centers. In addition to the biotech industry, just as all industries will be computer software over the next decades. And, they may not end up with data leaks, massive and expensive software teams, scientists, and senior management team wondering how they lost.
Case Study Overview
In highly regulated industries, you can count on the fact that your company will be inspected a time or two by regulatory agencies and/or your clients. Most companies manage these inspections using a mixture of programs for different aspects of the inspection. A leading problem with that approach is that these programs do not communicate with each other or update automatically.
Ridding Manual Processes During Inspections
Thermo Fisher Scientific’s Viral Vector Services (VVS) division (formerly Brammer Bio) is a contract development and manufacturing organization (CDMO) with three cGMP facilities and over 100 successful client projects under their belt. With multiple facilities and clients, the VVS division was being inspected two times per month. During each of the inspections, the team was using multiple tools to manage inspections requests and to communicate between the inspection room, support room, and employee’s in the office.
Audits and inspections undoubtedly call for numerous teams working simultaneously to fulfill requests. When these teams are not in sync, opportunities for missed and incomplete request responses arise. This causes strain on the inspection process as well as on the employee’s tasks.
For these reasons, Thermo Fisher brought on AuditUtopia®. Prior to AuditUtopia, Thermo Fisher managed the communication and requests surrounding the inspection using manual tools to communicate with those outside of the inspection room.
For example, the team would use a shared Microsoft OneNote folder to keep notes and track requests. The OneNote method required the team to enter basic information such as request number and type of request and track the progress of the request manually by refreshing the OneNote file. This made communication difficult and left notes unorganized.
The Cost of a Failed Regulatory Inspection
With the cost of a failed regulatory inspection approaching hundreds of thousands of dollars, the VVS division needed a dedicated solution to manage their regulatory and client inspections. Thermo Fisher’s VVS division soon found that one software, AuditUtopia®, stood above the rest for its responsiveness, ease of use, implementation program, and single platform solution for all their inspection management needs.
Switching to AuditUtopia®
For most companies, the thought of implementing a new software to replace an established system is daunting. PSC Software™ aims to mitigate the stress and learning curve that often comes with the implementation of a new software by providing trainers who are subject matter experts on the program along with recordings of the same trainings as a reference documents for future employees.
Gaining Peace of Mind While Achieving Results
Following a seamless implementation process, the Viral Vector Service’s inspection management team is able to stay organized and on-topic of the requests and inspection as a whole. Rather than playing “telephone”, the team is relying on first-hand, written accounts of what is being said in the inspection room.
The Thermo Fisher VVS team can now track the status of each request in real time and view metrics on where they struggle to answer requests in a timely, efficient manner. With the implementation successful, Thermo Fisher and PSC Software™ look forward to a successful long term partnership.
Pomona, Calif. October 15, 2019 – PSC Software™ announced today the release of ACE Essentials™, the complete turnkey electronic quality management system (EQMS) created for all highly regulated industries. This EQMS comes equipped with all the necessary standard operating procedures (SOPs) so you have a fully compliant quality management system from day one at an unbeatable price.
ACE Essentials™ was created to serve a multitude of industries: medical device, biotechnology, pharmaceutical, biopharmaceutical, food, active pharmaceutical ingredients, cannabis, nutraceuticals, and cosmetics. ACE Essentials™ workflows and procedures are wholly compliant with global regulations, and all updates are included in the annual price.
Charles Heldebrant, CSO of PSC Software™, says, “As a veteran in the life science industry, I understand how important it is to start off on the right foot, so I’m very pleased we are able to offer this product to those looking to accomplish that.”
ACE Essentials™ includes document management; training management; deviation, investigation and CAPA management; design control; risk management capabilities; and much more. ACE Essentials™ mitigates any future acquisition delays and regulatory body mishaps.
Brandon Clough, director of operations for the Midwest U.S. for PSC Biotech™, adds, “We’re excited to offer software that allows startups to build their quality programs quickly, with a near zero learning curve; all the while staying compliant.”
For a free demonstration or to learn more about ACE Essentials™, please contact Robert Kum at firstname.lastname@example.org.
About PSC Software™
PSC Software™, a division of PSC Biotech Corporation, provides inspection management and enterprise quality management software solutions enabling businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software™ address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers worldwide.
To learn more, visit pscsoftware.com.
+1 (617) 803-9193